AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study

Gainesville Eye Associates

Status

Completed

Conditions

Cataract

Treatments

Device: Panoptix

Study type

Observational

Funder types

Other

Identifiers

NCT04126187

CB-19-002

Details and patient eligibility

About

The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.

Full description

This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Enrollment

30 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option
Gender: Males and Females.
Age: 40 or older.
Willing and able to provide written informed consent for participation in the study.
Willing and able to comply with scheduled visits and other study procedures.
Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or a toric IOL in the approved ranged for the Panoptix lens.
Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

Irregular astigmatism (e.g. keratoconus)
Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)
Monocular status (e.g. amblyopia)
Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)
Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
Diabetic retinopathy
Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)
History of retinal detachment
Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.